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Ice Quake (Gadal Laboratories, Inc.)

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GEL 113 g in 1 TUBE (53113-100-01) Label Information

Complete Ice Quake Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredient

    Menthol 15%


  • PURPOSE

    Topical analgesic


  • Uses

    temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps

  • Warnings

    For external use only.

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • if severe burning sensation occurs, discontinue use immediately
    • do not expose the area treated with product to heat or direct sunlight.

    Stop use and ask a doctor if:

    • condition worsens
    • redness is present
    • irritation develops

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    adults and children over 18 years:

    • apply to affected area
    • squeeze desired amount of ICEQUAKE onto affected area
    • massage dispensed gel into painful area until thoroughly absorbed
    • repeat as necessary, but no more than 3 to 4 times daily.
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

  • Inactive Ingredients

    HPMC, Glycerine, FD&C blue #1, Carbopol, Isopropyl alcohol, Propylene glycol, Methylparaben, Sodium hydroxide, Purified water.


  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY:
    GADAL Laboratories, Inc. Miami, FL 33186


  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    ICEQUAKE
    Pain Relieving GEL
    Menthol
    15%

    Net wt 4 oz (113 g)

    Principal Display Panel - 113 g Tube Label

  • INGREDIENTS AND APPEARANCE
    ICE QUAKE 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 16.95 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Glycerin (UNII: PDC6A3C0OX)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Product Characteristics
    Color BLUE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53113-100-01 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part348 08/23/2012
    Labeler - Gadal Laboratories, Inc. (841305639)
    Establishment
    Name Address ID/FEI Business Operations
    Gadal Laboratories, Inc. 841305639 MANUFACTURE(53113-100)